Developing a patient-oriented realist evaluation for COVID-19 vaccine implementation in Saskatchewan: a methodologic framework.

BACKGROUND: There is an urgent need to inform decision-making and safe delivery of vaccines in a timely manner. Our objective is to describe the methods we used to perform a patient-oriented realist evaluation of COVID-19 vaccination implementation in Saskatchewan, Canada, in order to understand the underlying mechanisms and contexts of vaccination implementation and vaccine uptake. METHODS: This methodology paper describes a patient-oriented, realist, mixed-method evaluation to assess COVID-19 vaccination implementation in Regina, Saskatoon and Prince Albert, Saskatchewan. The study comprised 3 iterative phases guided by Realist And Meta-narrative Evidence Synthesis: Evolving Standards II (RAMESES II). In phase 1 (January-February 2021), we developed the initial program theory, in phase 2 (March-May 2021), we tested and refined the initial program theory, and in phase 3 (June-July 2021), we established the final program theory. Three patient and family partners with different backgrounds and experiences were selected purposively from various locations (urban and rural) in Saskatchewan to engage collaboratively in the evaluation. Data analysis and synthesis occurred at all 3 phases of the project. We analysed qualitative data from phases 2 and 3 using a "retroductive" approach. We used quantitative data to compare outcomes from the 3 sites. INTERPRETATION: This protocol describes how we developed a final program theory for COVID-19 vaccination implementation with patient and family partners to show for whom, under what circumstances, how and why Saskatchewan's COVID-19 vaccination program has led to vaccine uptake. With patient and family partners' engagement, the evaluation findings will be shared with the Saskatchewan Health Authority and provincial government policy-makers and communications departments, published in peer-reviewed journals, presented at provincial or national conferences, and disseminated through any additional media identified by the patient and family partners.

A rapid realist review of patient engagement in patient-oriented research and health care system impacts: part one.

BACKGROUND: Patient-oriented research affords individuals with opportunities to genuinely contribute to health care research as members of research teams. While checklists and frameworks can support academic researchers' awareness of patient engagement methods, less guidance appears available to support their understanding of how to develop and maintain collaborative relationships with their patient partners. This knowledge is essential as patient partners report that the social atmospheres of research teams significantly impacts the quality of their experiences. This study sought to develop theory regarding how academic researchers support and sustain patient engagement in patient-oriented research. METHODS: A six-step, rapid realist review was conducted: (1) research question development, (2) preliminary theory development, (3) search strategy development; (4) study selection and appraisal, (4) data extraction, analysis and synthesis (5) identification of relevant formal theories, and (6) theory refinement with stakeholders. Findings were additionally distilled by collective competence theory. RESULTS: A program theory was developed from 62 international studies which illuminated mechanisms supporting academic researchers to engage patient partners, contexts supporting these mechanisms, and resources that enabled mechanism activation. Interaction between seven contexts (patient-oriented research belief, prior interaction with a healthcare system, prior interaction with a particular academic researcher, educational background of patient partner, prior experience with patient-oriented research, study type, and time lived in a rural-urban setting) and seven mechanisms (deciding to become involved in patient-oriented research, recognizing valuable experiential knowledge, cultural competence, reducing power differentials, respectful team environment, supporting patient partners to feel valued, and readiness to research) resulted in an intermediate outcome (sense of trust). Trust then acted as an eighth mechanism which triggered the final-level outcome (empowered patient-centred lens). CONCLUSIONS: Our theory posits that if patient partners trust they are a member of a supportive team working alongside academic researchers who authentically want to incorporate their input, then they are empowered to draw upon their experiential knowledge of health care systems and contribute as researchers in patient-oriented research. Our theory extends conceptual thinking regarding the importance of trust on patient-oriented research teams, how patient partners' trust is shaped by team interactions, and the role that academic researchers have within those interactions.

Patient-oriented research gives patients, families, and caregivers opportunities to become members of health care research teams. Although academic researchers may be aware of what patient engagement is, they may not understand how to develop effective relationships with their patient partners. Academic researchers need this guidance because earlier research has shown that patient partners want to be supported to feel like they are important members of research teams. This support empowers them to feel confident to share their lived experiences and make suggestions and decisions about a research study. If patient partners believe their experiences and knowledge were not used or valued by academic researchers, then they may feel that their involvement was tokenistic. Tokenistic experiences discourage patient partners from participating in another research study.We conducted a rapid realist review of 62 international studies to explore what works (and does not work) in patient-oriented research. This methodology supported us to examine existing research and better understand what contexts, how and why patient-oriented research led to outcomes on a health care system. The goal of this type of research study is to develop and refine a program theory that identifies how actions and activities lead to outcomes.Our program theory emphasizes that patient partners need to trust the academic researchers they are working with. Several categories of actions (academic researcher's behavior) helped researchers to gain the trust of their patient partners. Academic researchers were more (or less) likely to act in these ways depending on several contextual factors. Once patient partners trusted academic researchers on the team, they were empowered to draw upon their lived knowledge of health care systems and actively contribute as researchers. These findings are part of our complete theory about patient-oriented research impacts. They highlight why it is important to gain patient partners' trust and how a complex set of actions are required by academic researchers to gain that trust.

Developing a program theory of patient engagement in patient-oriented research and the impacts on the health care system: protocol for a rapid realist review.

BACKGROUND: The patient-oriented research (POR) discourse has been criticized as being fragmented, lacking consistent terminology and having few evaluative studies. Our research team will use rapid realist review methodology to generate broad, process-based program theory regarding how partnering patients with researchers in POR generates an impact within a health care system. METHODS: This protocol for a rapid realist review will involve multiple steps, including research question development; preliminary program theory and search strategy development; study selection and appraisal; data extraction, analysis and synthesis; and program theory refinement. We will be guided by the Realist and Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) publication standards for realist synthesis. Unlike traditional reviews, a realist review aims to discover and understand causal processes that exist within a complex environment, asking questions regarding what works for whom, under what circumstances, how and why. Our multidisciplinary team consists of patient partners, health care professionals, a health sciences librarian and health services researchers. Patient partners are full research partners, supporting development of our guiding research question and identifying community partners and stakeholder groups to disseminate our findings. Patient partners will be asked to recommend literature sources, to review and vet our set of search terms, and to review, evaluate and reflect on our initial program theory in light of their personal, lived expertise. INTERPRETATION: We will share the results of our rapid realist review with community partners and stakeholder groups. We will also disseminate our program theory by means of publication in a peer-reviewed journal and presentation at scientific conferences.

One size does not fit all: a qualitative content analysis of the importance of existing quality improvement capacity in the implementation of Releasing Time to Care: the Productive Ward™ in Saskatchewan, Canada.

BACKGROUND: Releasing Time to Care: The Productive Ward™ (RTC) is a method for conducting continuous quality improvement (QI). The Saskatchewan Ministry of Health mandated its implementation in Saskatchewan, Canada between 2008 and 2012. Subsequently, a research team was developed to evaluate its impact on the nursing unit environment. We sought to explore the influence of the unit's existing QI capacity on their ability to engage with RTC as a program for continuous QI. METHODS: We conducted interviews with staff from 8 nursing units and asked them to speak about their experience doing RTC. Using qualitative content analysis, and guided by the Organizing for Quality framework, we describe the existing QI capacity and impact of RTC on the unit environment. RESULTS: The results focus on 2 units chosen to highlight extreme variation in existing QI capacity. Unit B was characterized by a strong existing environment. RTC was implemented in an environment with a motivated manager and collaborative culture. Aided by the structural support provided by the organization, the QI capacity on this unit was strengthened through RTC. Staff recognized the potential of using the RTC processes to support QI work. Staff on unit E did not have the same experience with RTC. Like unit B, they had similar structural supports provided by their organization but they did not have the same existing cultural or political environment to facilitate the implementation of RTC. They did not have internal motivation and felt they were only doing RTC because they had to. Though they had some success with RTC activities, the staff did not have the same understanding of the methods that RTC could provide for continuous QI work. CONCLUSIONS: RTC has the potential to be a strong tool for engaging units to do QI. This occurs best when RTC is implemented in a supporting environment. One size does not fit all and administrative bodies must consider the unique context of each environment prior to implementing large-scale QI projects. Use of an established framework, like Organizing for Quality, could highlight the distinctive supports needed in particular care environments to increase the likelihood of successful engagement.

Taking a closer look: using statistical process control to identify patterns of improvement in a quality-improvement collaborative.

BACKGROUND: Published reports suggest that there is considerable variation in improvement capacity and capability among participants in quality improvement collaboratives. Generating knowledge about why these complex initiatives do or do not work in different contexts requires both qualitative and quantitative approaches. Time-series analysis using line graphs and statistical process control is a rigorous quantitative approach with relatively unexplored potential in evaluating complex quality improvement interventions. AIM: The purpose of this study was to apply and illustrate the use of line graphs and statistical process control to identify variation in improvement among practices participating in the Saskatchewan Chronic Disease Management Collaborative. METHODS: The authors used line graphs and regression analysis to determine whether improvement occurred at the aggregate level, and small multiples, rational ordering and rational subgrouping to examine differences in the level and rate of improvement among practices. RESULTS: Small multiples allowed us to observe qualitative differences in patterns of improvement among practices. Stratifying data for all subgroups on one control chart using rational subgrouping provided quantitative evidence for these differences. Stratification by administrative health region using rational ordering showed consistent differences, indicating that the health region in which the practice was located may play a role in these differences. Results from the study are being used to inform a purposive sampling strategy for interviews with participants to explore why these differences occurred.

Examination of physical activity in adolescents over the school year.

This study monitored the physical activity behavior of adolescent students over a ten month school year. Physical activity was assessed at two month intervals using self-report and objective (Actical accelerometers) measures. Self-report results (n = 547) indicated a decline in physical activity throughout the school year for all grades and genders. The decline was attributed largely to a decrease in organized activity participation. Objective physical activity results (n = 40) revealed a significant decline in activity in the latter half of the school year (February to June). Declining physical activity was attributed to a decrease in vigorous activity which was consistent across grade and gender. Collectively, the results highlight the importance of promoting consistent opportunities for adolescents to be active throughout the school year.

Community-based communication strategies to promote infant iron nutrition in northern Canada.

OBJECTIVES: To evaluate innovative communication strategies promoting iron nutrition for infants at risk for iron deficiency anemia (IDA) in a northern Aboriginal community. STUDY DESIGN: A prospective process evaluation. METHODS: A social marketing approach was used in the development, implementation and evaluation of the communication strategies. A post-intervention questionnaire was administered to a sample (n = 45) to evaluate reach and exposure of the strategies, and sales of iron-rich infant foods were examined pre- and post-intervention. RESULTS: Multiple communication channels were associated with an increased awareness of IDA and an increased self-reported use of iron-rich infant food. Radio was the most successful channel for reach and exposure of messages. Iron-rich infant food sales increased from pre- to post-intervention (p < 0.05). Breadth of exposure to cooking activity was more limited; however, participants reported increased confidence in preparing homemade baby food. CONCLUSIONS: Communication strategies are a promising strategy for infant IDA prevention where appropriate food is available.

Impact of a food-based approach to improve iron nutrition of at-risk infants in northern Canada.

BACKGROUND: We evaluated the impact of a food-based approach in promoting iron-rich complementary feeding for mothers with infants at-risk for iron deficiency anemia (IDA). METHODS: A repeat cross-sectional design was used to assess the impact of communication strategies to disseminate key messages promoting iron-rich complementary food. Two groups of mothers with infants, aged 7-10 months, at Time 1 (n = 32; response rate = 64%) and Time 2 (n = 22; response rate = 48%) were interviewed. Main outcome variables were infants' total iron and complementary food iron intakes measured by two 24-h recalls. RESULTS: Complementary food iron intake increased between Time 1 (3.2 +/- 0.8 mg) and Time 2 (4.4 +/- 1.1 mg) (P < 0.05). The estimated prevalence of inadequacy was 56% (95% CI = 38%, 74%) for infants at Time 1 and 41% (95% CI = 20%, 62%) for infants at Time 2; however, this difference was not statistically significant. CONCLUSIONS: A food-based approach, promoted in a community with infants at-risk for IDA, can positively contribute to improved intake of complementary food iron as well as provide a sustainable and relevant prevention strategy.

Anxiety about food supply in cree women with infants in Quebec.

OBJECTIVES: The objectives were to document the prevalence of maternal anxiety about food supply in Cree women who had 9-month-old infants, and to understand maternal and infant characteristics associated with anxiety. STUDY DESIGN: The design was descriptive and combined both cross-sectional and retrospective analyses. METHODS: The study took place in nine Cree communities in northern Quebec. Data on maternal characteristics in pregnancy (age, parity, anemia, smoking status) and infant characteristics (gestational age, birth weight, weight and hemoglobin concentration at 9 months old) were obtained from medical records. At 9 months postpartum, mothers were asked about infant feeding practices, the health of their infant, and the question, "Do you ever worry you don't have enough money to buy your children food to eat?" Affirmative responses were considered evidence for anxiety about food supply. Pricing data was collected for commercial baby food, formula, milk and water in the communities and, for comparison, in the large urban city of Montreal. RESULTS: 245 woman-infant pairs participated. One-fifth (20.8%) of mothers were anxious about food supply. The prevalences of anxiety in women who had anemia, or smoked, during pregnancy, or who bottle-fed their 9-month-old infants, were 44.4%, 27.5% and 24.0%, respectively. The corresponding prevalences of anxiety in women who did not have anemia, who did not smoke, or who breastfed without bottle-feeding at 9-months postpartum, were 19.0%, 13.6% and 6.7%. The adjusted ORs for anxiety were 3.10 (95% CI, 1.11-8.65), 2.12 (95% CI, 1.05-4.29) and 3.87 (95% CI, 1.12-13.36) for anemia, smoking and bottle-feeding, respectively. Prevalences of anemia and infection were comparable between infants of mothers who did and did not express anxiety. However, infants whose mothers had anemia during pregnancy had higher prevalences of anemia (44.0% vs. 24.6%, p = 0.04) and infection (77.8% vs. 50.2%, p = 0.03) at 9 months old. CONCLUSION: Women who had anxiety about food supply for their children had characteristics that distinguished them from women who did not have anxiety. Anxiety was associated with anemia and smoking during pregnancy, and with bottle-feeding at 9 months postpartum.

Children with Cerebral Palsy: Caregivers' Nutrition Knowledge, Attitudes and Beliefs.

Knowledge is lacking about the feeding relationship between caregivers and children with cerebral palsy (CP). In this relationship, the child's dependency and the caregiver's influence on the child's nutrition may be magnified. A questionnaire was developed to examine caregivers' nutrition knowledge, attitudes, and beliefs. Reliability and validity were pretested with groups independent of the study. The questionnaire was administered to CP caregivers (n=52, 34% response rate) and a comparison group of non-CP caregivers (n=35). Over half of the children with CP were mildly to moderately affected by physical disability and presented with few oral-motor difficulties. Caregivers' perceptions of children's feeding behaviour did not differ between the two groups (p>0.05). Significant differences were evident in nutrition knowledge, as well as on one of two attitude scales and one of two belief scales measured. Non-CP caregivers scored higher in nutrition knowledge (p<0.001), had a more positive attitude about the importance of nutrition (p<0.05), and had a more positive belief in the relationship between nutrition and health (p<0.05). Results suggest that non-nutritional factors may have a higher priority with those caring for children with CP. Further investigation is warranted to examine the role that nutrition has in the care of children with various degrees of disability from CP. and inflammatory modulation.